(28 days)
The Wholey Guide Wire System is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guide wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
The Wholey™ Guide Wire System is a 0.035" guide wire available in lengths of 145, 175, 260 and 300cm. The distal tip flex configurations are Standard, Floppy, and Intermediate. Tip shape is Straight or Modified J. The guidewire is composed of a stainless steel core, green PTFE (polytetrafluoroethylene) coated coil, white PTFE sleeve, platinum-tungsten marker coil, and optional extension system connector. The proximal end of the core is covered by a white PTFE sleeve that terminates at 100cm from the distal tip. The distal 100cm of the guidewire is covered with a green PTFE pre-coated coil. The PTFE coated coil and platinum-tungsten coil are welded to the core on the very distal tip. The distal tip is shapeable and radiopaque.
A torque device is packaged with the guide wire as an accessory. The polycarbonate/brass torque device is designed to be secured to the proximal portion of a guide wire with a diameter, from 0.020" - 0.040" (0.50mm to 1.01mm) to facilitate steering of the guide wire within the vascular anatomy.
A Wholey Extension Wire is an available accessory consisting of a PTFE coated stainless steel guide wire attachment which is 0.035" (0.900 mm) in diameter and 155 cm in length. It is exclusively compatible with 0.035" (0.900 mm) Wholey guide wires which have been modified for the attachment of the Wholey Guide Wire Extension to facilitate device exchange. Refer to the Wholey Guide Wire Extension instructions for use.
This document describes the performance data for the Wholey™ Guide Wire System. However, it does not present acceptance criteria in a structured table or specifically detail a study proving the device meets those criteria in a quantitative sense as might be done for an AI/CADe device. Instead, it outlines a series of tests performed to establish substantial equivalence to a predicate device.
Here's an attempt to structure the information based on the provided text, while acknowledging the limitations of the original document in providing explicit acceptance criteria and a "study that proves" this in a clear, quantifiable manner typical of AI device evaluations:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests performed to demonstrate equivalence. While explicit numerical acceptance criteria are not provided for each test, the general statement is that "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
| Acceptance Criteria Category (Implied) | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Equivalence | Distal Pull Strength | Met requirements / Demonstrated equivalence |
| Combined Load Torque Response | Met requirements / Demonstrated equivalence | |
| Tip Flexibility | Met requirements / Demonstrated equivalence | |
| Coating Durability | Met requirements / Demonstrated equivalence | |
| Lubricity and Catheter Compatibility | Met requirements / Demonstrated equivalence | |
| Linear Stiffness | Met requirements / Demonstrated equivalence | |
| Dimensional | Met requirements / Demonstrated equivalence | |
| Fracture - ISO Flex - ISO | Met requirements / Demonstrated equivalence | |
| Corrosion | Met requirements / Demonstrated equivalence | |
| Strength of Union – Distal Tip | Met requirements / Demonstrated equivalence | |
| Shape Retention | Met requirements / Demonstrated equivalence | |
| Tip Load | Met requirements / Demonstrated equivalence | |
| Hypotube Flex | Met requirements / Demonstrated equivalence | |
| Jacket Adhesion | Met requirements / Demonstrated equivalence | |
| Body Stiffness (3-Point Bend) | Met requirements / Demonstrated equivalence | |
| Particulate | Met requirements / Demonstrated equivalence | |
| Radiopacity | Met requirements / Demonstrated equivalence | |
| Lateral Stiffness | Met requirements / Demonstrated equivalence | |
| Biocompatibility | Cytotoxicity (per ISO 10993 series) | Test results met the specified acceptance criteria. |
| Thrombogenicity (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Kligman Maximization Test (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Systemic Toxicity (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Rabbit Pyrogen (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Hemolysis (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Complement Activation Assay (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Lee and White Coagulation (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Unactivated Thromboplastin Time Assay (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| USP Physicochemical Test (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Inhibition and Enhancement (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Packaging | Pouch Peel | Met requirements / Demonstrated equivalence |
| Dye Penetration | Met requirements / Demonstrated equivalence | |
| Packaging Distribution | Met requirements / Demonstrated equivalence | |
| Thermal Conditioning | Met requirements / Demonstrated equivalence | |
| In Vivo Performance | GLP animal study | Showed the Wholey Guide Wire System is substantially equivalent to the currently marketed predicate device for safety and performance. |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for each bench test. For the GLP animal study, the sample size is not specified but it is referred to as "a GLP animal study."
- Data Provenance: The document refers to "bench testing" and "a GLP animal study." The location or specific country of origin for this testing is not specified, but it was conducted by Covidien LLC, an American company. The studies were likely prospective in nature for their specific evaluation goals.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this submission. The "ground truth" for non-clinical device testing, especially for mechanical and biocompatibility evaluations, is typically defined by standardized test methods (e.g., ISO standards, FDA guidance) and measured physical properties, rather than expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on direct measurements from bench tests and animal study observations, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This submission is for a medical device (guide wire system), not an AI/CADe system. Therefore, MRMC studies involving human readers or AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This submission is for a medical device (guide wire system), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation derived from:
- Physical Measurements and Standards: For bench tests, adherence to specified physical properties (e.g., pull strength, flexibility, dimensions) as defined by established engineering and material science standards, and guided by FDA and ISO guidance (e.g., ISO 11070:1998 for guidewires).
- Biocompatibility Testing Standards: Adherence to biological safety criteria as defined by ISO 10993 series for cytotoxicity, thrombogenicity, etc.
- In Vivo Observations: The GLP (Good Laboratory Practice) animal study provided observational data on safety and performance in a biological system, compared against the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so no "training set" in that context was used. The device design and testing were informed by existing knowledge, engineering principles, and regulatory guidance, not an iterative training process using a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI/ML device.
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APR 1 9 2012
Image /page/0/Picture/1 description: The image shows the number K120863 at the top. Below the number is the COVIDIEN logo. The logo is a square with a white shape inside of it, followed by the word COVIDIEN in all caps.
510(k) Summary
Wholey™ Guide Wire System
| 510(k) Summary | This summary of 510(k) safety and effectiveness information isbeing submitted in accordance with the requirements of 21C.F.R § 807.92. |
|---|---|
| Applicant | Covidien llc, formerly ev3, Inc. |
| Submitter | Covidien llc3300 Campus Drive, Suite N550Plymouth, MN 55441Tel: 763-398-7000Fax: 763-591-3248 |
| Contact Person | David RobertsonRegulatory Affairs Specialist |
| Date Prepared | February 3, 2012 |
| Device Trade Name | Wholey™ Guide Wire System |
| Device CommonName | Catheter Guide Wire |
| Classification Name | Wire, Guide, Catheter (21 CFR 870.1330), Product Code DQX |
| Classification Panel | Cardiovascular |
| Predicate Devices | Advanced Cardiovascular Systems Inc., Wholey™ Hi-Torque®Guide Wire (K861765) |
| Device Description | The Wholey™ Guide Wire System is a 0.035" guide wireavailable in lengths of 145, 175, 260 and 300cm. The distal tipflex configurations are Standard, Floppy, and Intermediate. Tipshape is Straight or Modified J. The guidewire is composed of astainless steel core, green PTFE (polytetrafluoroethylene) coatedcoil, white PTFE sleeve, platinum-tungsten marker coil, andoptional extension system connector. The proximal end of thecore is covered by a white PTFE sleeve that terminates at 100cmfrom the distal tip. The distal 100cm of the guidewire is coveredwith a green PTFE pre-coated coil. The PTFE coated coil and |
| platinum-tungsten coil are welded to the core on the very distaltip. The distal tip is shapeable and radiopaque. | |
| A torque device is packaged with the guide wire as an accessory.The polycarbonate/brass torque device is designed to be securedto the proximal portion of a guide wire with a diameter, from0.020" - 0.040" (0.50mm to 1.01mm) to facilitate steering of theguide wire within the vascular anatomy. | |
| A Wholey Extension Wire is an available accessory consistingof a PTFE coated stainless steel guide wire attachment which is0.035" (0.900 mm) in diameter and 155 cm in length. It isexclusively compatible with 0.035" (0.900 mm) Wholey guidewires which have been modified for the attachment of theWholey Guide Wire Extension to facilitate device exchange.Refer to the Wholey Guide Wire Extension instructions for use. | |
| Indication for Use | The Wholey Guide Wire System is intended to facilitate theplacement and exchange of interventional devices duringdiagnostic or therapeutic interventional procedures. The guidewire can be torqued to facilitate navigation through tortuousarteries and/or avoid unwanted side-branches. |
| Performance data | Bench testing and a GLP animal study were performed tosupport a determination of substantial equivalence. Results fromthis testing provide assurance that the proposed device has beendesigned and tested to assure conformance to the requirementsfor its intended use. Test methods were developed using FDACoronary and Cerebrovascular Guidewire guidance and ISO11070:1998 in order to demonstrate equivalence of the WholeyGuide Wire System to the predicate device. A list of applicablenon-clinical tests included performed at baseline and one yearaging include: |
| Distal Pull Strength Combined Load Torque Response Tip Flexibility Coating Durability Lubricity and Catheter Compatibility Pouch Peel Dye Penetration Linear Stiffness Dimensional Visual Fracture - ISO Flex - ISO Corrosion Strength of Union – Distal Tip Shape Retention Tip Load Hypotube Flex Jacket Adhesion Body Stiffness (3-Point Bend) Particulate |
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|---|---|
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| 763-333-7200 | |
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Radiopacity
and Packaging Distribution
Thermal Conditioning
Wholey™ Guide Wire System 510(k) Summary
.
Lateral Stiffness
| acceptance criteria.Cytotoxicity | Biocompatibility testing per ISO 10993 series was performed onthe Wholey Guide Wire System and test results met the specifiedThrombogenicity | ||
|---|---|---|---|
| ��0 | KligmanMaximization TestSystemic ToxicityRabbit PyrogenHemolysisComplementActivation Assay | Lee and WhiteCoagulationUnactivatedThromboplastin TimeAssayUSP PhysicochemicaTestInhibition andEnhancement | |
| criteria. | A GLP animal study was completed to evaluate safety andpredicate device for the evaluated safety and performance | performance of the Wholey Guide Wire System compared to thecurrently marketed predicate device. The study showed theWholey Guide Wire System is substantially equivalent to the | |
| Summary ofSubstantialEquivalence | �●● | the predicate devices:Similar basic design and fundamental scientifictechnologySimilar operating principleSimilar core wire materialsSimilar wire diameterSimilar wire lengthsSimilar tip styles | The Wholey Guide Wire System has the following similarities to |
| The characteristics that differ from the predicate device are the: | |||
| ●●● | Distal core headRadiopaque marker coilPTFE coated distal 8cmLack of intermediate joint at 8cmLack of adhesive between coil and sleeve | ||
| Carolian | 3033 Camble Drive | ﺮ ﻣﺮﻳﻜ753-398-7000 (T) | |
| タンさんなのです。 Nici | 783-398-7200 (E) |
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- White PTFE sleeve .
- . Braze extension adapter
Based on the similar indications for use, technological Conclusion characteristics, and results from in-vitro and in-vivo testing, Covidien IIc considers the Wholey™ Guide Wire System substantially equivalent to the Wholey™ Hi-Torque® Guide Wire (K861765).
| CRITICAL: | 3033 Carters Drive | 763-393-7000 [T] |
|---|---|---|
| Plymouth, MN | 763-393-7200 [F] | |
| 55441 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 9 2012
Covidien LLC c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K120863
Trade/Device Name: Wholey Guide Wire System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (Two) Product Code: DQX Dated: March 21, 2012 Received: March 22, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Mark Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
A. Hilleben
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health ·
Enclosure
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Page 1 of 1
Indications for Use Statement .
510(k) Number (if known): K120863
Device Name: Wholey Guide Wire System
Indications for Use:
The Wholey Guide Wire System is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guide wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. A. Hilliam
(Division Sign-Off) (Division Sign-oll)
Division of Cardiovascular Devices
510(k) Number K120863
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.